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Cardiovascular disease Healthy

A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the Skin

Locations

Netherlands

Start date

03/10/2024

Identifiers

Trial ID NN6537-7650,
NCT number NCT06625307,
Eudract number Not Available

Summary

The study is testing a new medicine to potentially treat people with heart failure. The main purpose of the study is to see if the new study medicine is safe and how it works in the body. It is the first time NNC0537-1482 (the new study medicine) is tested in humans and will be tested in healthy individuals (men and postmenopausal women). Participant will either get NNC0537-1482 or placebo (a "dummy medicine" without any active ingredients). Which treatment the participant get is decided by chance and the participant will only get either the study medicine or placebo on one occasion. It will be injected under the skin of the stomach by the study staff and the number of injections will depend on the cohort participant is assigned to. NNC0537-1482 cannot be prescribed by doctors. The study consists of 6 cohorts (groups) with 6 different dosing levels. The study will last for about 9 months. Participation in the study will last up to 42 days (depending on the cohort participant are assigned to) with an additional screening period that can be up to 28 days. Participant will have up to 10 visits to the clinic during the study period. However, the total number of visits depend on which cohort participant is assigned to.

Trial Overview:

Condition

Healthy Volunteers

Heart Failure

Treatment

DRUG: NNC0537-1482

DRUG: Placebo

Study type

INTERVENTIONAL

Trial duration

Oct 03 2024 - Jul 15 2025

Participants

56

Phase

I

Are you eligible?

Gender

Male and female

Age

22 to 55 years old

Questions or concerns

Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.

This site contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of a healthcare professional and should not be construed as providing advice or making a recommendation. The information on this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific product is correct for a particular patient. If you have questions regarding any information contained on this site you should consult a physician.